A Study Evaluating Venetoclax in Combination With Azacitidine in Subjects With Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)

  • Interventional
  • Recruiting
  • NCT02942290
Eligibility Details Visit Clinicaltrials.gov

A Phase 1b Dose Escalation Study Evaluating the Safety and Pharmacokinetics of Venetoclax in Combination With Azacitidine in Subjects With Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)

This is a Phase 1b, open-label, non-randomized, multicenter, dose-finding study evaluating venetoclax in combination with azacitidine in subjects with treatment-naïve higher-risk MDS comprising a dose-escalation portion and a safety expansion portion.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - Participant must have documented diagnosis of de novo MDS with:

             - International Prognostic Scoring System (IPSS) risk categories Int-2 or High (IPSS overall score ≥ 1.5) and

             - Presence of less than 20% bone marrow blasts per bone marrow

         - Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2.

         - Participant is not a candidate to undergo intensive chemotherapy or allogeneic hematopoietic stem cell transplantation (HSCT).

        Exclusion Criteria:

         - Participant has received prior therapy for MDS. (Prior supportive care in form of transfusions or growth factors, etc., is not considered prior therapy.)

         - Participant has received prior therapy with a BH3 mimetic.

         - Participant has a diagnosis other than previously untreated de novo MDS with IPSS risk categories Int-2 or High, including:

             - MDS with IPSS risk categories Low or Int-1 (overall IPSS score < 1.5)

             - Therapy-related MDS (t-MDS)

             - MDS evolving from a pre-existing myeloproliferative neoplasm (MPN)

             - MDS/MPN including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (CML), juvenile myelomonocytic leukemia (JMML) and unclassifiable MDS/MPN

         - Participant has received allogeneic HSCT or solid organ transplantation.

         - Participant has received a live attenuated vaccine within 4 weeks prior to the first dose of study drug.

At a Glance

National Government IDNCT02942290

IRB#IRB16-1363

Lead SponsorAbbVie

Lead PhysicianOlatoyosi Odenike

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting